Medical Econet
⚠️ Moderate Risk
FEI: 3004378576 • Seoul • SOUTH KOREA
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2007 | 85HGMSYSTEM, MONITORING, PERINATAL | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 5/25/2007 | 85HGMSYSTEM, MONITORING, PERINATAL | Florida District Office (FLA-DO) | |
| 2/6/2007 | 90IZLSYSTEM, X-RAY, MOBILE | Florida District Office (FLA-DO) | |
| 6/29/2006 | 90IZLSYSTEM, X-RAY, MOBILE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medical Econet's FDA import refusal history?
Medical Econet (FEI: 3004378576) has 4 FDA import refusal record(s) in our database, spanning from 6/29/2006 to 6/15/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Medical Econet's FEI number is 3004378576.
What types of violations has Medical Econet received?
Medical Econet has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Medical Econet come from?
All FDA import refusal data for Medical Econet is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.